VELCADE (Bortezomib) for Injection Based Regimens Result in Lower Costs and Less Patient Burden Than Other Commonly Used Multiple Myeloma Treatment Regimens

New Data Released at ASH Examine Convenience and
Cost-Effectiveness of Common Multiple Myeloma Treatment
Regimens

NEW ORLEANS--(BUSINESS WIRE)--Dec 6, 2009 -
Millennium: The Takeda Oncology Company today announced that
two studies presented at the 51st American Society of Hematology
(ASH) Annual Meeting found that VELCADE based regimens are more
cost-effective for payers and reduced out-of-pocket costs for
patients than other commonly used multiple myeloma treatments. The
study found that VELCADE-melphalan-prednisone (VMP), a commonly
used treatment in multiple myeloma, was more cost-effective
compared to MP and delivered more cost-savings compared to
melphalan-prednisone-thalidomide (MPT), another commonly used
treatment regimen, based on a health economic model.

A second study based on claims data found patients with multiple
myeloma treated with VELCADE:

Did not require significantly
more healthcare visits than patients prescribed thalidomide and
lenalidomide.

“These studies support VELCADE's overall
cost-effectiveness and reduced out-of-pocket costs. As measured by
the number of healthcare visits, VELCADE appears to be as
convenient as oral multiple myeloma treatments,” said
Dixie-Lee Esseltine, M.D., Vice President, Global Medical Affairs,
Millennium. “This is valuable information for healthcare
providers, patients and payers.”

The Cost-Effectiveness of Bortezomib for the Initial
Treatment of Multiple Myeloma in the United States (Abstract
#1379)

Based on a direct comparison of patient-level data,
researchers projected that VMP would be cost-effective over a
patient's lifetime compared with MP in the United States. A second
indirect comparison across different trials projected the
combination of VMP would cost payers 17.7 percent less over a
patient's lifetime and generate better quality-adjusted life
expectancy than MPT. Quality-adjusted life years are a measure of
disease burden that take into account both the length and quality
of life.

The incremental cost-effectiveness of VMP versus MP was found to
be within the generally accepted cost-effectiveness range of
$50,000-$100,000 per quality-adjusted life year. The projected
overall survival years were greatest for patients treated with VMP
versus those treated with MPT or MP (4.19, 4.14, and 2.86 years,
respectively).

“Cancer can be a costly disease for both payers and
patients, and this is certainly true in multiple myeloma,”
said Professor Lou Garrison, a study co-author and Associate
Director in the Pharmaceutical Outcomes Research and Policy
Program, Department of Pharmacy, University of Washington, Seattle.
“It is therefore important to identify cost-effective
therapies. This trial-based modeling study demonstrates that the
first-line regimen using VELCADE is cost-effective compared to
other commonly used regimens.”

To assess the relative costs and outcomes of different treatment
combinations, study methodology generated modeling projections
based on a direct comparison from the Phase III VISTA1
trial, which demonstrated superiority in overall survival of VMP
versus MP (San Miguel et al, New England Journal of Medicine
2008) for treatment of multiple myeloma, as well as an indirect
comparison of this trial with data published from the IFM 99-06
clinical trial for MPT (Facon et al, Lancet 2007). Costs
included per-protocol drug and medical costs, treatment-related
adverse events, second-line treatment, and resource utilization
during treatment-free interval and progressive disease. Unit costs
of medications were obtained from published literature.

In the second study, researchers used data from one of the
largest U.S. commercial healthcare plans to evaluate the number of
healthcare visits and out-of-pocket costs for multiple myeloma
patients being treated with various therapies. After adjusting for
patient characteristics, line of treatment, and co-morbidities by
multivariate analysis, data showed that patients receiving VELCADE
did not have a significantly different number of healthcare visits
than those receiving lenalidomide or thalidomide, two oral
therapies. Additionally, direct out-of-pocket costs were found to
be significantly lower for patients treated with VELCADE than
patients treated with thalidomide or lenalidomide.

“There is a common perception that oral drugs are more
convenient for patients, but these data show that, in terms of
healthcare visits, that perception of convenience is false,”
said study author Brett W. Pinsky, i3 Innovus researcher.
“These data are consistent with the fact that patients with
multiple myeloma typically require a great deal of care and
resource utilization; therefore, most patients will not see a major
difference in the number of healthcare visits regardless of whether
their treatment is oral or infusion – but they may face a
significantly higher out-of-pocket cost with oral
medications.”

The total patient out-of-pocket costs for the year after
treatment initiation were significantly less for patients treated
with VELCADE ($3,504) than for those treated with either of the
oral drugs thalidomide ($4,443, p<0.05) or lenalidomide ($4,766,
p<0.05), after adjusting for patient characteristics, line of
treatment, and co-morbidities by multivariate analysis. These
differences were greatest for Medicare patients, with the adjusted
patient costs nearly two and three times greater for thalidomide
($8,824) and lenalidomide ($12,568), respectively, compared with
VELCADE ($4,395).

The study is a retrospective cohort study, which used claims
data from a large national U.S. commercial health plan representing
approximately 14 million members, and included a total of 2,642
treatment episodes for the 1,900 multiple myeloma patients.

Both studies were supported by Millennium Pharmaceuticals, Inc.
The Wang study was also supported by Johnson & Johnson
Pharmaceutical Research and Development, L.L.C.

About Multiple Myeloma

Multiple myeloma is the second most common hematologic
malignancy and although the disease is predominantly a cancer of
the elderly (the median age of onset is 70 years), recent
statistics indicate both increasing incidence and younger age of
onset. In the U.S., more than 50,000 individuals have MM and 20,000
new cases are diagnosed each year. Worldwide there are
approximately 74,000 new cases and over 45,000 deaths annually.

About VELCADE

VELCADE is co-developed by Millennium Pharmaceuticals, Inc. and
Ortho Biotech Oncology Research & Development, a unit of
Johnson & Johnson Pharmaceutical Research & Development,
L.L.C., and approved worldwide. Millennium is responsible for
commercialization of VELCADE in the U.S., Janssen-Cilag is
responsible for commercialization in Europe and the rest of the
world. Janssen Pharmaceutical K.K. is responsible for
commercialization in Japan. VELCADE is approved in more than 87
countries worldwide.

Important Safety Information

In the U.S., VELCADE is indicated for the treatment of patients
with multiple myeloma. VELCADE also is indicated for the treatment
of patients with mantle cell lymphoma who have received at least
one prior therapy. VELCADE is contraindicated in patients with
hypersensitivity to bortezomib, boron or mannitol. VELCADE should
be administered under the supervision of a physician experienced in
the use of antineoplastic therapy.

Risks associated with VELCADE therapy include new or worsening
peripheral neuropathy, hypotension throughout therapy, cardiac and
pulmonary disorders, reversible posterior leukoencephalopathy
syndrome, gastrointestinal adverse events, thrombocytopenia,
neutropenia, tumor lysis syndrome and hepatic events. Women of
childbearing potential should avoid becoming pregnant while being
treated with VELCADE. Nursing mothers are advised not to breastfeed
while receiving VELCADE. Cases of severe sensory and motor
peripheral neuropathy have been reported. The long-term outcome of
peripheral neuropathy has not been studied in mantle cell lymphoma.
Acute development or exacerbation of congestive heart failure, and
new onset of decreased left ventricular ejection fraction has been
reported, including reports in patients with no risk factors for
decreased left ventricular ejection fraction. There have been
reports of acute diffuse infiltrative pulmonary disease of unknown
etiology such as pneumonitis, interstitial pneumonia, lung
infiltration and Acute Respiratory Distress Syndrome in patients
receiving VELCADE. Some of these events have been fatal. There have
been reports of Reversible Posterior Leukoencephalopathy Syndrome
(RPLS) in patients receiving VELCADE. RPLS is a rare, reversible,
neurological disorder which can present with seizure, hypertension,
headache, lethargy, confusion, blindness, and other visual and
neurological disturbances. VELCADE is associated with
thrombocytopenia and neutropenia. There have been reports of
gastrointestinal and intracerebral hemorrhage in association with
VELCADE. Transfusions may be considered. Complete blood counts
(CBC) should be frequently monitored during treatment with VELCADE.
Cases of acute liver failure have been reported in patients
receiving multiple concomitant medications and with serious
underlying medical conditions. Patients who are concomitantly
receiving VELCADE and drugs that are inhibitors or inducers of
cytochrome P450 3A4 should be closely monitored for either
toxicities or reduced efficacy. Patients on oral antidiabetic
medication while receiving VELCADE should check blood sugar levels
frequently.

Adverse Reaction Data

Safety data from Phase II and III studies of single-agent
VELCADE 1.3 mg/m2/dose twice weekly for 2 weeks followed
by a 10-day rest period in 1163 patients with previously treated
multiple myeloma (N=1008, not including the Phase III, VELCADE plus
DOXIL® [doxorubicin HCl liposome injection] study)
and previously treated mantle cell lymphoma (N=155) were integrated
and tabulated. In these studies, the safety profile of VELCADE was
similar in patients with multiple myeloma and mantle cell
lymphoma.

Millennium: The Takeda Oncology Company, a leading
biopharmaceutical company based in Cambridge, Mass., markets
VELCADE, a first-in-class proteasome inhibitor, and has a robust
clinical development pipeline of product candidates. Millennium
Pharmaceuticals, Inc. was acquired by Takeda Pharmaceutical Company
Ltd. (“Takeda”, TSE: 4502) in May, 2008. The Company's
research, development and commercialization activities are focused
in oncology. Additional information about Millennium is available
through its website,
www.millennium.com.

Editors' Note: This press release is also available under the
Media section of the Company's website at:
www.millennium.com.

1VELCADE as
Initial Standard Therapy: Assessment with melphalan and
prednisone

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